FDA.reportPublic FDA data

CODMAN

Primary DI
10886704001225
Brand
CODMAN
Company
Cerenovus, Inc.
Model
20-1604
Catalog number
201604
Device description
CODMAN SLIM-LINE Aneurysm Clip Straight Blade Length 15mm
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCHCLIP, ANEURYSM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091921000CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIPCodman & Shurtleff, Inc.2009-09-08HCH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704001225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670400122510886704001225

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysm clipA metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603703679LAZICPeter Lazic GmbHHCH2025-10-30
04250603703778LAZICPeter Lazic GmbHHCH2025-10-30
04250603703860LAZICPeter Lazic GmbHHCH2025-10-30
04250603709527LAZICPeter Lazic GmbHHCH2025-08-07
04250603714835LAZICPeter Lazic GmbHHCH2025-08-07
04250603733911LAZICPeter Lazic GmbHHCH2025-08-07
04250603753018LAZICPeter Lazic GmbHHCH2025-06-30
04250603727194LAZICPeter Lazic GmbHHCH2025-06-16
04250603734031LAZICPeter Lazic GmbHHCH2025-06-16
04250603733980LAZICPeter Lazic GmbHHCH2025-05-13
04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416763SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
G586N697205A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N697206A0NovosurgicalNOVO SURGICAL, INC.HCH2025-02-06
G586N6971710NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6971730NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
G586N6972700NovosurgicalNOVO SURGICAL, INC.HCH2025-01-02
04250603707424LAZICPeter Lazic GmbHHCH2024-09-12
04250603726791LAZICPeter Lazic GmbHHCH2024-03-25
04250603727057LAZICPeter Lazic GmbHHCH2024-03-25
00842331190506Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190513Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
00842331190520Novo Surgical Inc. NOVO SURGICAL, INC.HCH2024-01-07
04946329389340Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389357Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389364Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19
04946329389371Sugita AVM Microclip IIMIZUHO CORPORATIONHCH2023-12-19